MARKETING AUTHORIZATION APPLICATION REQUIREMENTS FOR VACCINES IN INDIA, EUROPEAN UNION, UNITED STATES
Journal of Disease and Global Health,
Page 12-22
Abstract
Vaccines contain agents which are often made from the microbe or its surface proteins or its toxins, which are eventually derived from the biological source. Before launching a new vaccine in the market, the rigorous regulatory procedure is required to assess the quality, efficacy and safety of the vaccine. U.S. Food and Drug Administration (FDA) Centre for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States. European Union (EU) follows five steps to regulate vaccine registration and regulation which are, marketing authorization application (MAA), registration, quality assessment, pharmacovigilance, post-license commitments and license renewals. In the case of India, vaccine registrations are regulated by the Drugs and Cosmetics Act, 1940.
Keywords:
- Centre for biologics evaluation and research
- marketing authorization application
- european union
- food and drug administration
- vaccines.
How to Cite
JOSHI, S. S., & BALAMURALIDHARA, V. (2021). MARKETING AUTHORIZATION APPLICATION REQUIREMENTS FOR VACCINES IN INDIA, EUROPEAN UNION, UNITED STATES. Journal of Disease and Global Health, 14(1), 12-22. Retrieved from https://ikppress.org/index.php/JODAGH/article/view/5810
References
US. Department of Health & Human Services- Vaccine Basics.
Available:https://www.vaccines.gov/ [Accessed on 11th January 2020]
Vaccine development, testing, and regulation. Available:https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation [Accessed on 11th January 2020]
Andrade EL,* Bento AF,* Cavalli J, Oliveira SK, Freitas CS, Marcon R, Schwanke RC, Siqueira JM, Calixto JB. Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies, online: Brazilian Journal of Medical and Biological Research; 2016.
USFDA. Center for Biologics Evaluation and Research (CBER); 2018.
Available:https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/center-biologics-evaluation-and-research-cber-responsibilities-questions-and-answers (Accessed: 27th December 2020).
Vaccines.
Available:https://www.fda.gov/BiologicsBloodVaccines/Vaccines/default.html [Accessed on 11th January 2020]
Europe union. about the EU. Available:https://europa.eu/european-union/about-eu/countries_en (accessed 27th December 2020).
European Union. European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe; 2020.
Available:https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-organisations-initiatives/european-directorate-quality-medicines-healthcare-edqm-council-europe (Accessed: 27th December 2020).
Research and development.
Available:https://www.ema.europa.eu/en/human-regulatory/research-development [Accessed on 25th Febraury 2020]
Nuthalakanti Nandini*, Priyanka B. Marketing authorization and strategies for the promotion of drugs in india, europe and usa. world Journal of Pharmacy and Pharmaceutical Sciences. 2020;8(8):336-352.
Indian kanoon. The Drugs and Cosmetics Rules; 1945.
Available:https://indiankanoon.org/doc/16293633/ (Accessed: 26th December 2020)
Central Drugs Standard Control Organisation (CDSCO). Available:https://cdsco.gov.in/opencms/opencms/en/Home/ [Accessed on 23rd March 2020]
CNBC. Top vaccine makers Merck and Pfizer target China and older adults next. Business News Health And Science. Sunday; 2019. Available:https://www.cnbc.com/2019/05/10/merck-pfizer-sanofi-pasteur-and-glaxosmithkline-make-billions-from-shingrix-and-gardasil-vaccines.html. [Accessed on 27th December 2020]
The Drugs and Cosmetics Act and Rules. Available:http://www.cdsco.nic.in/writereaddata/Drugs&CosmeticAct.pdf [Accessed on 11th January 2020]
CDSCO. Sugam.
Available:https://cdscoonline.gov.in/CDSCO/homepage(Accessed: 25th December2020).
Technical Guide for the elaboration of monographs on vaccines and other immunological human medicinal products. Available:https://www.edqm.eu/sites/default/files/technical_guide_for_the_elaboration_of_monographs_on_vaccines_and_other_immunological_human_medicinal_products.pdf [Accessed on 05th Febraury 2020]
Ana Mulero. EMA Fees See 1.7% Increase. Regulatory Focus™; 2019. Available:https://www.raps.org/news-and-articles/news-articles/2019/4/ema-fees-see-17-increase [Accessed on 27th December 2020]
Guidance for industry content and format of chemistry, manufacturing and controls information and establishment description information for a vaccine or related product. Available:https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm092272.pdf [Accessed on 13th Febraury 2020]
Application to market a new or abbreviated new drug or biologic for human use. Available:https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/ucm082348.pdf [Accessed on 22nd January 2020]
Blair Holbein ME. Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators. HHS Author Manuscripts. 2009;57(6):688-694.
FDA (). Conducting a clinical safety review of a new product application and preparing a Report on the Review.
Available:https://www.fda.gov/media/71665/download (Accessed: 28th December 2020).
Submitting study datasets for vaccines to the office of vaccines research &review.
Available:https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/UCM605147.pdf [Accessed on 25th January 2020]
ICH (). Stability testing of active pharmaceutical ingredients and finished pharmaceutical product.
Available: https://database.ich.org/sites/default/files/Q1F_Stability_Guideline_WHO_2018.pdf (Accessed: 28th December 2020).
European Union (). The European Medicines Agency (EMA) provides guidance on obtaining and maintaining a scientific opinion under the Article 58 procedure on high priority human medicines intended exclusively for markets outside of the European Union (EU).
Available: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/medicines-use-outside-eu-article-58/obtaining-maintaining-scientific-opinion-medicine-use-outside-european-union (Accessed: 28th December 2020).
Available:https://www.vaccines.gov/ [Accessed on 11th January 2020]
Vaccine development, testing, and regulation. Available:https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation [Accessed on 11th January 2020]
Andrade EL,* Bento AF,* Cavalli J, Oliveira SK, Freitas CS, Marcon R, Schwanke RC, Siqueira JM, Calixto JB. Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies, online: Brazilian Journal of Medical and Biological Research; 2016.
USFDA. Center for Biologics Evaluation and Research (CBER); 2018.
Available:https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/center-biologics-evaluation-and-research-cber-responsibilities-questions-and-answers (Accessed: 27th December 2020).
Vaccines.
Available:https://www.fda.gov/BiologicsBloodVaccines/Vaccines/default.html [Accessed on 11th January 2020]
Europe union. about the EU. Available:https://europa.eu/european-union/about-eu/countries_en (accessed 27th December 2020).
European Union. European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe; 2020.
Available:https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-organisations-initiatives/european-directorate-quality-medicines-healthcare-edqm-council-europe (Accessed: 27th December 2020).
Research and development.
Available:https://www.ema.europa.eu/en/human-regulatory/research-development [Accessed on 25th Febraury 2020]
Nuthalakanti Nandini*, Priyanka B. Marketing authorization and strategies for the promotion of drugs in india, europe and usa. world Journal of Pharmacy and Pharmaceutical Sciences. 2020;8(8):336-352.
Indian kanoon. The Drugs and Cosmetics Rules; 1945.
Available:https://indiankanoon.org/doc/16293633/ (Accessed: 26th December 2020)
Central Drugs Standard Control Organisation (CDSCO). Available:https://cdsco.gov.in/opencms/opencms/en/Home/ [Accessed on 23rd March 2020]
CNBC. Top vaccine makers Merck and Pfizer target China and older adults next. Business News Health And Science. Sunday; 2019. Available:https://www.cnbc.com/2019/05/10/merck-pfizer-sanofi-pasteur-and-glaxosmithkline-make-billions-from-shingrix-and-gardasil-vaccines.html. [Accessed on 27th December 2020]
The Drugs and Cosmetics Act and Rules. Available:http://www.cdsco.nic.in/writereaddata/Drugs&CosmeticAct.pdf [Accessed on 11th January 2020]
CDSCO. Sugam.
Available:https://cdscoonline.gov.in/CDSCO/homepage(Accessed: 25th December2020).
Technical Guide for the elaboration of monographs on vaccines and other immunological human medicinal products. Available:https://www.edqm.eu/sites/default/files/technical_guide_for_the_elaboration_of_monographs_on_vaccines_and_other_immunological_human_medicinal_products.pdf [Accessed on 05th Febraury 2020]
Ana Mulero. EMA Fees See 1.7% Increase. Regulatory Focus™; 2019. Available:https://www.raps.org/news-and-articles/news-articles/2019/4/ema-fees-see-17-increase [Accessed on 27th December 2020]
Guidance for industry content and format of chemistry, manufacturing and controls information and establishment description information for a vaccine or related product. Available:https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm092272.pdf [Accessed on 13th Febraury 2020]
Application to market a new or abbreviated new drug or biologic for human use. Available:https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/ucm082348.pdf [Accessed on 22nd January 2020]
Blair Holbein ME. Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators. HHS Author Manuscripts. 2009;57(6):688-694.
FDA (). Conducting a clinical safety review of a new product application and preparing a Report on the Review.
Available:https://www.fda.gov/media/71665/download (Accessed: 28th December 2020).
Submitting study datasets for vaccines to the office of vaccines research &review.
Available:https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/UCM605147.pdf [Accessed on 25th January 2020]
ICH (). Stability testing of active pharmaceutical ingredients and finished pharmaceutical product.
Available: https://database.ich.org/sites/default/files/Q1F_Stability_Guideline_WHO_2018.pdf (Accessed: 28th December 2020).
European Union (). The European Medicines Agency (EMA) provides guidance on obtaining and maintaining a scientific opinion under the Article 58 procedure on high priority human medicines intended exclusively for markets outside of the European Union (EU).
Available: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/medicines-use-outside-eu-article-58/obtaining-maintaining-scientific-opinion-medicine-use-outside-european-union (Accessed: 28th December 2020).
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